HIV Medication Adherence in Underserved Populations

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome

Treatments: Behavioral: Cognitive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT02392884

Pro00033072

Details and patient eligibility

About

The purpose of this study is to determine whether cognitive rehabilitation or psychoeducation impacts medication adherence in HIV-1 seropositive individuals.

Full description

Although antiretroviral therapy (ART) has proven extremely effective in the treatment of HIV and AIDS, the ability to effectively combat the disease is inconsequential when individuals do not take their medication as prescribed and do not attend their scheduled medical appointments. Non-adherence to effective ART and medical visits is widespread in the United States, especially among ethnic minorities. A recent study indicated that patients who miss a medical appointment in the first year of an HIV diagnosis show over twice the mortality rate of patients who attended all visits. This study is developed to investigate the relationship between HIV Associated Neurocognitive Disorder (HAND) and adherence to HIV treatment among traditionally marginalized populations. Participants will be administered a brief neuropsychiatric screener. Participants will be randomly enrolled one of two cognitive rehabilitation programs so they may learn compensatory cognitive strategies to remain treatment adherent, or they will be receive psychoeducation concerning the importance of taking their medications and regularly attending medical appointments. Participants will be tracked and followed-up with regarding their treatment adherence in regular intervals over the course of 6 months.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult, age 18 and older.
• Able and willing to provide written informed consent.
• Diagnosed as HIV-seropositive by licensed enzyme-linked immunoabsorbent assay (ELISA) or HIV-seropositive by Western blot (WB).
• Diagnosed as HIV seropositive within the last two years.
• Willing and able to provide adequate information for locator purposes.

Exclusion criteria

• Under the age of 18.
• Have ever sustained a traumatic brain injury.
• Have an obvious psychological/psychiatric disorder that would invalidate the informed consent process, or otherwise contraindicate participation in the study.
• Have a learning disability where they cannot read or write pass the third grade level.
• Have an active substance dependence diagnosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

EON-MEM

Active Comparator group

Description:

Intervention: Cognitive Rehabilitation and compensatory strategies will be taught to subjects to help them remember routes, viral load count, CD4 count, faces of providers and managing their schedules. Over the course of 5 visits, subjects will receive this intervention.

Treatment:

Behavioral: Cognitive Rehabilitation

Compensatory Cognitive Training

Active Comparator group

Description:

Cognitive Rehabilitation and physical reminders, such as calendars, smart phones, self-notes and other methods to help subjects remember to attend all medical appointments and take their HIV medication. Subject will be exposed to 5 sessions of this particular training.

Treatment:

Behavioral: Cognitive Rehabilitation

Psychoeducation

No Intervention group

Description:

The psychoeducation group, which aims to teach subjects the importance of taking medications and attending all doctor's appointment for HIV treatment. If you subjects are assigned to this group, they will be followed and receive the care generally followed for individuals with this condition.